Monogenic diabetes is an unusual form of diabetes. It usually presents in patients under the age of 30, so is often misdiagnosed as Type 1 diabetes which is more common. Patients with monogenic diabetes can often be treated with tablets rather than insulin injections, leading to better control of their diabetes, and fewer side-effects and complications. Less than 5% of people with monogenic diabetes in the UK have been identified, meaning up to 20,000 patients may still be misdiagnosed and receiving inappropriate treatment. We want to identify the best way of ensuring that people diagnosed with diabetes under the age of 30 have all the necessary tests to ensure they have the correct treatment for their particular type of diabetes. A small number of people may, as part of this study, be found to have a specific genetic cause of their diabetes and in these cases we will measure the success and benefits of changing their treatment, usually from insulin injections to sulphonylurea tablets.

Further study details as provided by NIHR Exeter Clinical Research Facility:

Primary Outcome Measures:

Identification of patients with monogenic diabetes [ Time Frame: Within 4 years from start of project ] [ Designated as safety issue: No ]

The aim of this project is to identify the prevalence of patients with monogenic diabetes resulting from mutations in the HNF1A/HNF4A/GCK genes, amongst patients with early-onset diabetes, diagnosed less than 30 years.

Secondary Outcome Measures:

To examine the impact of making a diagnosis of monogenic diabetes on patients' treatment, glucose control and quality of life. [ Time Frame: Within 4 years of the project start date. ] [ Designated as safety issue: No ]

To measure the impact of making a molecular genetic diagnosis of monogenic diabetes by examining at baseline, 1 month, 6 months and 12 months the following parameters:

i) treatment - both type and dose; ii) glucose control - measured by HbA1c at 3, 6 and 12 months post-treatment change; iii) quality of life - by appropriate protocols.

To develop a health economic model of the care pathway leading to testing of monogenic diabetes. [ Time Frame: Within 4 years of the project start date. ] [ Designated as safety issue: No ]

To develop a health economic model that can measure the success, cost and potential economic benefit of using the care pathway to identify patients with monogenic diabetes and potentially change their treatment. This will allow assessment of when testing is appropriate on health economic grounds.

Stage 3: review and potential change of diabetes treatment. Monitor success via use of three standardised health and quality of life questionnaires and Hba1c pre-treatment change and at 1, 3, 6 and 12 months post-treatment change.

Patients currently under the age of 50 years, diagnosed under the age of 30years, from South-West England and Tayside, Scotland, UK.

Criteria

Inclusion Criteria:

clinical diagnosis of diabetes

diagnosed under 30 years of ages

current age less than 50 years

willing and able to provide informed consent.

Exclusion Criteria:

age over 50 years

age at diagnosis over 30 years

adult with incapacity to consent

child with incapacity to assent

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01238380